Zacks_Analysts' Blog : Pfizer's Axitinib Encourages - Analyst Blog

Pfizer Inc. (PFE) recently presented encouraging data on its oncology candidate, axitinib, from a pivotal phase III study.

The AXIS 1032 trial, which was conducted in patients with previously treated advanced renal cell carcinoma (RCC), showed that patients in the axitinib arm experienced a significant improvement in progression free survival (median of 6.7 months compared with 4.7 months) compared to patients being treated with Bayer/Onyx Pharma’s (BAYRY/ONXX) Nexavar (sorafenib).

Pfizer reported that progression free survival was significantly longer in the axitinib arm irrespective of prior treatment with Sutent or cytokines. The company noted that axitinib lengthened median progression free survival to more than a year in the subset of patients who were previously treated with cytokines. Results from the study will be presented at the upcoming annual meeting of the American Society of Clinical Oncology (ASCO).

The approval of axitinib would provide advanced renal cell carcinoma patients, especially previously-treated patients, with an additional treatment option. According to Pfizer, kidney cancer is diagnosed in about 210,000 people every year with about 102,000 expected to die from the disease.

Although significant progress has been made in the treatment of kidney cancer, five-year survival rates still remain low at about 20%. Pfizer already has two drugs approved for kidney cancer – Sutent and Torisel.

Pfizer is working on filing for regulatory approval of axitinib for renal cell carcinoma. Axitinib is also in a phase III study that is being conducted with treatment-naïve as well as treatment-experienced patients suffering from advanced renal cell carcinoma. A phase II study, evaluating axitinib for the treatment of hepatocellular carcinoma, is also ongoing.

Neutral on Pfizer

We currently have a Neutral recommendation on Pfizer, which carries a Zacks #3 Rank (short-term Hold rating). While near-term earnings growth will come in the form of cost cutting and share repurchases, longer-term growth will be dependent on successful drug development. 2011 should be a catalyst-filled year for the company, which is expecting to present phase III data on several candidates including tofacitinib, Prevnar/Prevenar 13 and Eliquis.

Pfizer will face additional challenges later this year with the loss of US exclusivity on Lipitor in November.